Department of Health and Human Services July 10, 2013 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to FDA regulations for human tissue intended for transplantation.

HRSA is publishing Agency Guidance (``Policy Information Notice'' (PIN) 2013-01) to provide clarification on the budgeting and accounting requirements for federally-funded health centers and Look- Alikes. The PIN, ``Health Center Budgeting and Accounting Requirements'' is available on the Internet at https://bphc.hrsa.gov/ policiesregulations/policies/pin201301.html. Background: HHS' Health Resources and Services Administration (HRSA) provides grants to eligible health centers under section 330 of the Public Health Service Act to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. In 2012, grants helped fund more than 1,200 health center grantees that provided services at nearly 9,000 health care delivery sites and served more than 21 million people. There are also over 100 Look-Alikes. Look-Alikes, as described in section 1861(aa)(4) and section 1905(l)(2)(B) of the Social Security Act, do not receive federal funding under section 330 of the PHS Act; however, to receive the Look-Alike designation and benefits, Look-Alikes must meet the statutory, regulatory, and policy requirements for health centers programs under section 330. Under 45 CFR Part 74, a key requirement of the Health Center Program is for a health center to establish a budget that reflects the cost of operations, expenses, and revenues necessary to accomplish the service delivery plan. All section 330-funded health centers and Look- Alikes must prepare a budget that meets these requirements. The purpose of this PIN is to provide clarification regarding budgeting and accounting requirements for health centers to ensure transparency and accountability. In addition to making the final PIN available on HRSA's Web site, HRSA is also making available a section of this PIN for public comment. HRSA will review and analyze all comments on this section and issue final PIN. When finalized, this section of the PIN will supersede all other previous Health Center Program guidance and policy issued on this program requirement.